Design & DevelopmentCleanroom EnvironmentThermoformingAssembly & Contract packaging Complementary ProcessLaboratory & ValidationHeat Sealing Machines

Laboratory & Validation

Quality Assurance & Regulatory Affairs

Experienced–continuous
training–customer focus culture

People

continuous improvement–Lean

System

reliable–High technology–scalable

Equipment

traceability, SPC, capa pk, cpk
Change Control & risk analysis (FMEA product & process)

Control

Technical Files management, regulatory
compliance, normative forecasting

Regulatory Affairs

Packaging Validation

  • Laboratory

    The group invests relentlessly in equipments for its Quality Laboratory, where all control measures and tests are done. Some examples in two different application fields:

    Control of microbial contamination in ISO 7 & ISO5

    Microbiological contamination control of our ISO 7 & ISO5 clearnroom:
    Bacteriological controls,
    Biodurden testing,
    Control of air cleanliness (YY0033),
    Microbiological samples of air and surface areas (GB16293),
    Test reports on cleanroom performances etc.
    Micro insoluble particle inspection GB8368

    “Dimensional Laboratory” for the product control:
    Control during the manufacture,
    Batch Release

    Pull Strength

    Dye penetration test

    DYE test

    Cleanroom control

    Micro insoluble particle inspection

    x

    Under Construction

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